Acumen Assisted Fluid Management (AFM) Software Feature is an AI-enabled medical device from Edwards Lifesciences, LLC that the U.S. FDA cleared through 510(k) K233984 on August 2, 2024. Its lead review panel is Cardiovascular and its primary product code is QMS (Adjunctive Open Loop Fluid Therapy Recommender).
See also FDA-cleared AI cardiovascular devices in 2024, all FDA AI clearances in 2024, top cardiovascular AI devices.
Key facts
| Submission number | K233984 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Edwards Lifesciences, LLC |
| Lead review panel | Cardiovascular |
| Primary product code | QMS — Adjunctive Open Loop Fluid Therapy Recommender |
| Applicant (openFDA) | Edwards Lifesciences, LLC |
| Applicant location | Irvine, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.5600 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Acumen Assisted Fluid Management (AFM) Software Feature went through this pathway (K233984).
openFDA lists it as a Class 2 device under 21 CFR 870.5600. Class II devices are moderate risk and are subject to general and special controls.
Product code QMS covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Edwards Lifesciences, LLC has 3 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.